ASX Health Stocks: Compumedics granted FDA clearance; Botanix receives FDA feedback

Compumedics scores FDA approval for sleep device
FDA said Botanix’s materials for its NDA submission are acceptable
Alterity announced promising new data on the effect of ATH434 in Parkinson’s disease

FDA approves Compumedics sleep device

Medical device company, Compumedics (ASX:CMP), announced that the US FDA has cleared the Somfit device to be marketed in the USA.

The approval marks the achievement of a strategic milestone for the Somfit technology platform in one of the world’s largest sleep markets.

Compumedics can now begin its commercialisation activities in the key USA market, following initial commencement of sales activities for Somfit in the Australian market since the beginning of FY24. In Australia, sales of Somfit generated $1.2m of orders taken to date since the launch in July.

Compumedics believes there is significant addressable market in the US of between US$110m-180m in potential revenue, from which the company will target 10% to 30% of within the next 24 months.

The US has approximately 3,000 sleep centres, and 15 major Independent Diagnostic Testing Facilities (IDTFs). The home sleep testing (HST) market in the country is estimated at two million studies per annum.

Given the pre-FDA market research activities undertaken by Compumedics, this represents a potential new addressable market of between US$110m and US$180m a year in potential new and incremental SaaS (software as a service) revenues.

Compumedics has pre-emptively appointed a number of new sales staff in the US to commence initial commercialisation activities, and will be actively pursuing several focused opportunities available to it following the FDA clearance.

CMP believes the Somfit technology platform offers a clear competitive advantage, and superior value to alternate technologies on the market in the US, by being highly scalable, offering a clinical grade technology for use in the home, along with an overall reduced cost.

The Somfit device is worn on the patient’s forehead and collects the physiological data when the patient sleeps, which is then pressed onto the electrode. The Somfit houses the sensors and transmits the data to the App via Bluetooth.

Following this announcement, Compumedics has reaffirmed its FY24 guidance with revenues of more than $44m and EBITDA of more than $5m.

Botanix receives feedback from FDA

Botanix Pharmaceuticals (ASX:BOT) has received the expected feedback from FDA following its “end of review” Type A meeting request, in respect to the Sofdra new drug application (NDA) review.

The FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the planned resubmission of the Sofdra NDA package.

No additional materials have been requested by FDA as part of the resubmission. The submission of the final component required for FDA approval of Sofdra remains on target for early Q1 2024, with a likely six-month review process targeting FDA approval in mid-CY2024.

Sofdra is the trade name for Sofpironium Bromide, and is BOT’s lead product for the treatment of primary axillary hyperhidrosis.

Primary axillary hyperhidrosis is a chronic idiopathic disorder characterised by uncontrollable excessive sweating without a recognisable cause.

Alterity announces promising new data

Neurodegenerative diseases focused biotech, Alterity Therapeutics (ASX:ATH), announced that promising new data on the effect of ATH434 in a Parkinson’s disease primate model was presented at the Future of Parkinson’s Disease Conference that took place November 30 – December 3, 2023 in Austin.

The poster, entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian Macaques”, was presented by Margaret Bradbury, PhD, vice president of Research and Nonclinical Development at Alterity and collaborators from Vanderbilt University Medical Center and the Florey Institute of Neuroscience in Melbourne.

The presentation demonstrated that ATH434 treatment improved motor performance and general function in monkeys with experimentally induced Parkinson’s disease.

The favorable impact on Parkinson’s symptoms was associated with lower iron levels in the area of pathology. In addition, ATH434 treatment increased levels of synaptophysin, a protein marker that reflects functional connections between neurons.

Neurotech receives ethics approval

Paediatric neurological disorders focused biotech, Neurotech (ASX:NTI), announced a Human Research Ethics Committee (HREC) approval today.

The approval will extend the current Phase II/III clinical trial in Autism Spectrum Disorder (ASD) patients to allow for patients who turn 18 years of age to remain on treatment with NTI164, during the extension phase of the trial for up to 54 weeks of total treatment.

The current HREC approval covers treatment with NTI164 in a paediatric population of ASD.

“Importantly, with recruitment into the trial to complete during the current quarter, we are on track to report results during the first quarter of calendar year 2024 (Q3 FY24),” said Dr Thomas Duthy, executive director of Neurotech.